Brain and Central Nervous System TumorsPhase 1NCT00612001
Vaccine Therapy in Treating Patients With Malignant Glioma
A Phase 1 study testing glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine in people with Brain and Central Nervous System Tumors, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from peptides and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with malignant glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of 1 of the following malignant gliomas:
- Anaplastic astrocytoma
- Glioblastoma multiforme
- Oligodendroglioma
- Oligoastrocytoma
- WHO grade III or IV disease
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- Newly diagnosed or recurrent disease
- Bidimensionally measurable disease by contrast-enhancing MRI
- Surgically accessible tumor for which resection is indicated
- Previously treated with or planning to undergo treatment with conventional external beam radiotherapy
- HLA-A*201 positive
- Karnofsky performance status 60-100%
- Life expectancy ≥ 8 weeks
- Hemoglobin ≥ 10 g/dL
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- SGOT and SGPT ≤ 2 times normal
- Alkaline phosphatase ≤ 2 times normal
- Bilirubin ≤ 1.5 mg/dL
- BUN ≤ 1.5 times normal OR creatinine ≤ 1.5 times normal
- Negative pregnancy test
- Fertile patients must use effective contraception
- Hepatitis B negative
- Hepatitis C negative
- HIV negative
- Syphilis serology negative
- Afebrile
Who cannot join
- active infection
- immunodeficiency
- autoimmune disease that may be exacerbated by immunotherapy, including any of the following:
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Vasculitis
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- Polymyositis-dermatomyositis
- Scleroderma
- Multiple sclerosis
- Juvenile-onset insulin-dependent diabetes
- allergy to study agents
- underlying condition that would contraindicate study therapy
- concurrent severe or unstable medical condition that would preclude giving informed consent
- psychiatric condition that would preclude study participation or giving informed consent
- other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, localized prostate cancer, or carcinoma in situ of the cervix
- prior chemotherapy (6 weeks for nitrosoureas) within last 4 weeks of starting treatment
- concurrent corticosteroids within 2 weeks prior to treatment
- radiotherapy within 2 weeks prior to treatment
- systemic antibiotics within 72 hours prior to treatment
- prior organ allograft
- antihistamine therapy within 5 days before or after administration of study vaccine
- chemotherapy during and for 4 weeks after administration of study vaccine
- adjuvant therapy during and for 4 weeks after administration of study vaccine
- other concurrent investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients
RATIONALE: Vaccines made from peptides and a person's dendritic cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with malignant glioma.
Read the detailed description
OBJECTIVES:
- Determine the dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides in patients with malignant gliomas.
- Determine survival, tumor progression, and cellular immune response in patients treated with this regimen.
OUTLINE: Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC). Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF) and interleukin-4 (IL-4), matured with a cytokine cocktail, and pulsed with synthetic glioma-associated antigen (GAA) peptides. Cohorts of patients receive escalating doses of GAA peptide-pulsed autologous dendritic cell vaccine until the maximum tolerated dose is determined.
After completion of study treatment, patients are followed every 2 months for 1 year.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine
- Keywords
- adult anaplastic astrocytoma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult anaplastic oligodendroglioma, recurrent adult brain tumor, adult mixed glioma
- Medical subject headings
- Central Nervous System Neoplasms, Astrocytoma, Glioblastoma, Gliosarcoma, Oligodendroglioma, Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glioma-associated antigen peptide-pulsed autologous dendritic cell vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| dendritic cell vaccine | Experimental | Not described Receives: Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides
Measured: 3 months
Survival
Measured: 1 year
Tumor progression
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startMay 2006
- Primary completionJan 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Linda M. Liau, MD, PhD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612001
- Sponsor's protocol ID
- CDR0000585166
- Other IDs
- R01CA112358, UCLA-06-01-052
- Status last verified
- Aug 2013
- First submitted
- 8 Feb 2008
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prins RM, Wang X, Soto H, Young E, Lisiero DN, Fong B, Everson R, Yong WH, Lai A, Li G, Cloughesy TF, Liau LM. Comparison of glioma-associated antigen peptide-loaded versus autologous tumor lysate-loaded dendritic cell vaccination in malignant glioma patients. J Immunother. 2013 Feb;36(2):152-7. doi: 10.1097/CJI.0b013e3182811ae4.
PubMed 23377664
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients
- ClinicalTrials.gov ID
- NCT00612001
- Acronym / sponsor ID
- CDR0000585166
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult anaplastic astrocytoma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult anaplastic oligodendroglioma, recurrent adult brain tumor, adult mixed glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Vaccines made from peptides and a person's dendritic cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with malignant glioma.
Detailed description
OBJECTIVES:
- Determine the dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides in patients with malignant gliomas.
- Determine survival, tumor progression, and cellular immune response in patients treated with this regimen.
OUTLINE: Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC). Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF) and interleukin-4 (IL-4), matured with a cytokine cocktail, and pulsed with synthetic glioma-associated antigen (GAA) peptides. Cohorts of patients receive escalating doses of GAA peptide-pulsed autologous dendritic cell vaccine until the maximum tolerated dose is determined.
After completion of study treatment, patients are followed every 2 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dendritic cell vaccine | Experimental | Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Histologically confirmed diagnosis of 1 of the following malignant gliomas:
- Anaplastic astrocytoma
- Glioblastoma multiforme
- Oligodendroglioma
- Oligoastrocytoma
Key exclusion criteria (24 listed)
- active infection
- immunodeficiency
- autoimmune disease that may be exacerbated by immunotherapy, including any of the following:
- Rheumatoid arthritis
- Systemic lupus erythematosus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine | Biological | dendritic cell vaccine |
Primary outcome
Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides
Time frame: 3 months
Survival
Time frame: 1 year
Tumor progression
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
- Derived from this study: PubMed 23377664Prins RM, Wang X, Soto H, Young E, Lisiero DN, Fong B, Everson R, Yong WH, Lai A, Li G, Cloughesy TF, Liau LM. Comparison of glioma-associated antigen peptide-loaded versus autologous tumor lysate-loaded dendritic cell vaccination in malignant glioma patients. J Immunother. 2013 Feb;36(2):152-7. doi: 10.1097/CJI.0b013e3182811ae4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda M. Liau, MD, PhD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine in people with Brain and Central Nervous System Tumors, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00612001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.